Quality Assurance

QA Specialists are available to consult with investigators, upon request, on quality-related issues and protocol compliance; provide their expertise to confirm study conduct is according to Federal regulations, ICH GCP guidelines, university policies and all other applicable regulations and provide feedback and suggestions.

For regulatory agency inspections, YCCI QA supports and leads the preparation of study documents, notification to Yale leadership and applicable ancillary groups and acts as a liaison between the inspector and the PI and study team during the course of the inspections.

If notified of a regulatory agency inspection, such as FDA or EMA, please contact the YCCI Associate Director of Quality Assurance, immediately: Nancy S. Shelton, M.B.E.C., CCRP, CHRC .

Further details about the inspections are provided under Regulatory Agency Inspection (FDA, EMA, etc.)

The YCCI Quality Assurance team conducts internal audits, in partnership with the Yale Human Subjects Protection Program (HRPP), using risk-based stratification methods.

Please see review the steps below to get a brief idea on the audit process:

1. Audit Notification
2. Introductory Meeting with the PI, study team, and YCCI, HRPP representatives, as applicable
3. Records Review (Regulatory, Cases and Pharmacy)
4. Exit Interview (Review of observations with the PI and study team)
5. Final Summary (Action Items are lsited as "Recommendations" or "Required Response")
6. Response to Action Items, if any, by the PI and study team

QA specialists are available to review study documents per investigator/ study team request. These reviews are typically requested if the investigator is notified of a sponsor GCP audit or if the investigator is approached by a study sponsor requesting to conduct a pre-inspection visit, which generally occur once the study sponsor submits a marketing application to the regulatory agencies. The QA Specialists are available to assist the investigators to review study documents to identify and correct deficiencies prior to these visits as well as address any concerns with the sponsor.

To request a preparatory review, please contact the YCCI Associate Director of Quality Assurance, immediately: Nancy S. Shelton, M.B.E.C., CCRP, CHRC.

YCCI QA provides support to investigators who have been notified that they may undergo a regulatory inspection, thereby reducing the regulatory and reporting burden on investigators and teams before, during, and after inspections.

If you are contacted by a sponsor or regulatory agency notifying you of an imminent inspection, please contact the YCCI Associate Director of Quality Assurance, immediately: Nancy S. Shelton, M.B.E.C., CCRP, CHRC.

Additionally, contact the Yale HRPP, the IRB of record and the study sponsor informing them of the inspection notice.

All regulatory agency inspections are hosted at a central dedicated location by YCCI.

Tips inspection preparedness:

• Ensure that the study sponsor has the most up-to-date contact information for the principal investigator listed on the FDA 1572 or Statement of Investigator.
• Ensure all study documents – paper and/or electronic – are available, complete and organized
• Plan to adjust PI’s schedule, if possible, to be available to meet periodically with the inspector - typically for introductory meeting, agreed upon intermittent times and at exit meeting.
• Note down the full name and the contact information (phone number and email) for the agency inspector upon notification

Additional References:

• FDA
  • CPG Sec. 130.300 FDA Access to Results of Quality Assurance Program Audits and Inspections
  • Bioresearch Monitoring Program (BIMO) Compliance Programs
• EMA
• Health Canada
• PMDA

YCCI QA is available to review inspection, external audit and monitoring report findings and to conduct a root cause analysis (RCA) in order to methodically identify the root causes of findings, so that they may be addressed.

YCCI QA will also support the investigator in developing a Corrective and Preventive Action (CAPA) plan to ensure corrective actions and preventative improvements to processes can be taken to eliminate causes of non-compliance.

To request a Root Cause Analysis or support with CAPA development, please contact the YCCI Associate Director of Quality Assurance: Nancy S. Shelton, M.B.E.C., CCRP, CHRC.

The guidance documents, study tools and templates are provided to aid research teams with documenting required regulatory and protocol information, tracking study procedures and organizing study documents.

Click on each subheading to review the available documents.

Note: You must be on the Yale University or Yale-New Haven Hospital network to view this page. If you are off-site, please connect through VPN.

If you have questions, please contact the YCCI Associate Director of Quality Assurance: Nancy S. Shelton, M.B.E.C., CCRP, CHRC.